At the 2017 annual meeting of the Maui Derm for Dermatologists, Novartis presented new data from the A2302E1 study which suggest that Cosentyx (secukinumab) could change the course of psoriasis, with approximately 20% of patients achieving maintenance of skin clearance after stopping treatment for one year. Datamonitor Healthcare believes that these data could allow Cosentyx to be positioned earlier in the treatment algorithm and become a market leader in psoriasis.
Cosentyx was the first interleukin (IL)-17 to enter the psoriasis market, gaining Japanese approval in Q4 2014, and US and EU approval in Q1 2015. The drug acts by neutralizing the pro-inflammatory cytokine IL-17A, which is secreted by activated T cells. Cosentyx has had a successful launch and has already achieved impressive sales of $1.1bn in 2016, largely driven by excellent skin efficacy data.
Cosentyx demonstrated the ability to modify the course of psoriasis, addressing a key unmet need
Cosentyx’s ability to modify the course of psoriasis is of particular importance, since achieving disease remission in psoriasis is one of the top three treatment challenges encountered, according to Datamonitor Healthcare’s 2016 primary research survey with dermatologists. There are currently no therapies which have demonstrated the ability to achieve disease remission after discontinuation of therapy, giving a competitive edge for Cosentyx in the psoriasis market, and further boosting its clinical attractiveness.
In the double-blind, placebo-controlled extension study (A2302E1), 120 psoriasis patients treated with Cosentyx for one year were randomized to either continue treatment with a 300mg dose, or halt treatment until relapse. The positive results showed that patients in the placebo arm sustained low Psoriasis Area Severity Index (PASI) scores, with scores of 2.9 after one year and 1.7 after two years, compared with 20.5 and 19.2 at baseline. Among the PASI 75 responders who discontinued treatment to receive placebo, 21% and 10% of patients were relapse-free after one and two years, respectively. Additionally, the probability of relapse was higher for patients who initiated treatment with Cosentyx later, after onset of the disease.
Impressive skin data have boosted Cosentyx’s uptake and positioned it as one of the preferred biologics
Cosentyx has already enjoyed a successful market penetration due to strong efficacy data and a comprehensive clinical development, which has placed it as a preferred option for moderate-to-severe psoriasis patients. In the head-to-head FIXTURE trial (ClinicalTrials.gov identifier: NCT01358578), Cosentyx demonstrated clear superiority compared with the anti-tumor necrosis factor agent Enbrel (etanercept; Amgen/Pfizer/Takeda). Similarly, in the CLEAR study (ClinicalTrials.gov identifier: NCT02074982), Cosentyx was superior to its main rival Stelara (ustekinumab; Johnson & Johnson). As a result, Cosentyx has gained a strong position for the management of psoriasis.
Novartis is aiming to capture additional patient share with the STEPIn trial
In a bid to reposition Cosentyx earlier in the treatment algorithm for psoriasis, Novartis announced the initiation of the STEPIn trial (ClinicalTrials.gov identifier: NCT03020199) to evaluate the effects of Cosentyx in patients with new onset of moderate-to-severe plaque psoriasis compared with standard treatment with light therapy. Should Cosentyx demonstrate the ability to reverse the disease with early treatment, this could convince payers to prescribe Cosentyx at first line, before using phototherapy or the cheaper anti-TNF biosimilars, since patients could benefit from real, long-term improvements in their disease.